At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 168 enrolled
Drug / intervention
Vaxelis™biological
Likely dose
Vaxelis™ 0.5 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 4, Open-label, Multicenter Study to Evaluate the Safety, Tolerability, and Immunogenicity of Vaxelis™ in Healthy Children Previously Vaccinated With a 2-Dose Primary Infant Series of Either Vaxelis™ or Hexyon™
In Brief
A Phase 4 clinical trial evaluating Vaxelis™ for Vaccines, Combined and Hexavalent Vaccine. Completed, enrolled 168 participants across 13 sites in 3 countries.
Detailed Summary
The primary objectives of this study are to evaluate the safety, tolerability, and immunogenicity of a booster dose of Vaxelis™ (V419) given at \~11 to 13 months of age in healthy participants who were previously vaccinated with a 2-dose primary infant series of either Vaxelis™ or Hexyon™.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVaccines, Combined, Hexavalent Vaccine
CountriesGermany, Italy, Spain
Collaborators--
Timeline
Phase 4CompletedFinished
2023202420252026
First PostedMar 2022
Enrollment StartMar 2022
Primary CompletionAug 2022
TodayJul 2026
First PostedMar 21, 2022
Enrollment StartMar 25, 2022
Primary CompletionAug 30, 2022
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 4.3 years ago
Interventions
Vaxelis™biological
Vaxelis™ 0.5 mL sterile suspension in prefilled syringe for intramuscular administration.